Associate Scientist

Job Description

Job Summary:

• Possesses an understanding of laboratory procedures and under general supervision can conduct complex analysis.
• Trains on routine operation, maintenance and theory of analytical instrumentation, SOPs and regulatory guidelines.
• Responsible for review and compilation of results and data comparison a Products SOP acceptance criteria, methodology, protocol and product specifications.
• The Associate Scientist will perform the following activities for the process development of large molecule drug substances.
• They will be responsible for implementing and optimizing experimental protocols, performing experiments and authoring scientific reports in the areas of purification, chemical modification, process development and scale-up of polysaccharides intermediates and drug substances.
• The Associate Scientist will be responsible for implementing and optimizing process and execution of downstream processes at different scales and in different research and development contexts.

Duties and Responsibilities:

• Completion of process development experiments to support early development, optimization, scale-up and tech transfer for vaccine development programs.
• Complete the design and execution of experiments to support process development of Client vaccine programs from preclinical through clinical stages with minimal supervision, maintaining good scientific practice.
• Focus on the development of new processes or improvement of existing processes using scientific expertise, literature review or by seeking inputs from Subject Matter Experts.
• Perform organic reactions and purify the intermediates or products independently
• Complete analysis and/or characterization of intermediates or drug substances
• Complete data analysis from process development studies
• Complete Tech transfer of developed processes to support GMP manufacturing.
• Complete archiving of raw and processed data as per Client policy
• Operate and maintain designated lab equipment and train others as needed.
• Complete additional duties and responsibilities as required.
• Complete the documentation of experimental results as per GMP/GLP regulations.
• Complete the authoring of technical reports in collaboration with QA / RA / MSAT / ARD teams at client and assist in submission to regulatory agencies such as FDA.

Education and Experience:

• Bachelor’s degree or equivalent and relevant formal academic / vocational qualification
• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 0 to 2 years).
• In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

Knowledge, Skills and Abilities:

• Industry experience with process development preferred.
• Knowledge in Carbohydrate Chemistry or Synthetic Organic Chemistry preferred.
• Experience in analytical chemistry and familiar with NMR, MS, HPLS, SEC/MALS preferred
• Independent, detail-oriented, and organized with excellent oral and written communication skills.
• Demonstrated ability to work in a dynamic environment as a team player with a strong work ethic.
• Ability to carry and move solvents, reagents, waste solvents or small equipment for up to 40 pounds in the lab.
• Ability to maintain written records in the form of laboratory notebooks / electronic lab notebooks (ELNs).